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Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators…
The major change in medical decision making over the last 50 years has been the realisation that treatment decisions would be improved if doctors’ existing knowledge was supplemented by evidence generated systematically through health services…
Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…
February 26, 2021 – EMA has recommended granting a marketing authorisation in the European Union (EU) for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic…
This is the first Medical Writing Biotechnology regular section. Biotechnology is a broad subject. It can be defined by the use of biological systems and living organisms in production processes. Biotechnology has been around for thousands of years.…
What a year! A year of corona, crisis, and challenges. But also a year of innovations, break - throughs, and opportunities. I am one to focus on silver linings and here are some to think about. I am immensely proud of being part of an industry that…
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
Clinical trials are becoming more complex and the efforts to optimise drug development are rapidly evolving. This Q&A gives a short overview of the strategies Bristol Myers Squibb implements to incorporate diversity into the clinical trial…
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common childhood disorders. First described in 1798 by Alexander Crichton, ADHD became widely known outside the medical profession with the publication of the story of Fidgety Phil…
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